CLARINEX MAKER SUES OVER GENERICS

NOVEMBER 01, 2006

A bid by a generic company in Largo,
Fla, to produce a generic version of the
allergy medication Clarinex (desloratadine)
has been blocked by a lawsuit
from Schering-Plough Corp, makers of
the brand drug. The pharmaceutical
company has sued GeoPharma Inc and
its subsidiary, Belcher Pharmaceuticals,
in federal court in New Jersey for
patent infringement. The suit is tied to
Belcher's filing for a generic version of
Clarinex 5-mg tablets with the FDA.

Schering's lawsuit also names 12
other pharmaceutical companies that
filed for rights to generic Clarinex at
the same time as Belcher. Sales of
Clarinex in 2005 reached $325 million,
and, although competition was expected
to be tight, Mihir Taneja, chief executive
of GeoPharma, was surprised
that so many others were lining up to
make generic Clarinex as well. He and
the other defendants are claiming that
their versions of the allergy drug are
bioequivalent to the brand version but
do not infringe on Schering's patent,
which expires in June 2007. The FDA
can approve the generic filings if
the complaint is not resolved in 30
months.